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    The EU Clinical Trials Register currently displays   42174   clinical trials with a EudraCT protocol, of which   6938   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-002213-18
    Sponsor's Protocol Code Number:EDP938-103
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-002213-18
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Adult Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well the drug EDP 938-102 works and how safe it is in people who have had a bone marrow transplant and are infected with Respiratory Syncytial Virus
    A.4.1Sponsor's protocol code numberEDP938-103
    A.5.4Other Identifiers
    Name:INDNumber:135874
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEnanta Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEnanta Pharmaceuticals. Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnanta Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617607 0705
    B.5.6E-mailnadda@enanta.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEDP-938
    D.3.2Product code EDP-938
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEDP-938
    D.3.9.1CAS number 2070852-76-3
    D.3.9.2Current sponsor codeEDP-938
    D.3.9.3Other descriptive nameEDP-938
    D.3.9.4EV Substance CodeSUB214949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory syncytial virus (RSV)
    E.1.1.1Medical condition in easily understood language
    Respiratory syncytial virus is the leading cause of lower respiratory tract infection and presents a significant health challenge in small children, elderly, and people with weak immune systems
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of EDP-938 on the development of lower respiratory tract
    complication (LRTC) in HCT subjects with an acute RSV URTI
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of EDP-938 on RSV viral load as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) of nasopharyngeal swab samples
    • To evaluate the effect of EDP-938 on progression to respiratory failure or all-cause mortality
    • To evaluate the progression of RSV infection using the InFLUenza Patient-Reported Outcome questionnaire
    • To evaluate the pharmacokinetics (PK) of EDP-938 and its metabolites
    • To evaluate the safety and tolerability of EDP-938
    • To evaluate the effect of EDP-938 on infectious RSV viral load in nasopharyngeal swab samples as determined by a quantitative cell-based infectivity assay
    • To evaluate the relationship between the PK of EDP-938 and antiviral and clinical efficacy
    • To evaluate the incidence of major clinical events
    • To evaluate the length of hospital stay and time in the (ICU)
    • To evaluate the use of certain therapeutics
    • To evaluate the emergence of viral resistance with EDP-938 treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. An ICF signed and dated by the subject
    2. Male or female individuals aged between 18 and 75 years, inclusive
    3. Received an autologous or allogeneic HCT using any conditioning regimen
    4. Absolute lymphocyte count (ALC) <500 cells/ μL
    5. Laboratory confirmed RSV diagnosis from a respiratory sample obtained not more than 3 days prior signing the ICF. The RSV diagnosis can be determined by any validated laboratory method.
    6. New onset of at least one of the following respiratory symptoms within 3 days before signing the ICF: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis [eg, chronic rhinorrhea, chronic lung disease]) in the 3 days before signing the ICF or at Screening.
    7. No evidence of new abnormalities consistent with LRTI on a chest X-ray performed in the 2 days before signing the ICF. If there is no chest X-ray available in the 2 days before signing the ICF, a chest X-ray must be obtained at the Screening visit.
    8. Oxygen saturation ≥92% on room air.
    9. A body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
    10. Negative urine pregnancy test for women of childbearing potential as defined in inclusion criterion #11.
    11. A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug. Effective methods of contraception are defined as follows:
    A condom for the male partner and at least one of the following for the female subject:
    a. Intrauterine device
    b. Occlusive cap (diaphragm or cervical/vault caps)
    c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive
    The above does not apply to a female subject who has a vasectomized male as the sole partner or who is of nonchildbearing potential (ie, physiologically incapable of becoming pregnant) as defined below:
    a. Has had a complete hysterectomy ≥3 months before Screening,
    b. Has had a bilateral oophorectomy (ovariectomy),
    c. Has had a bilateral tubal ligation or fallopian tube inserts, or
    d. Is postmenopausal (a total cessation of menses for at least 2 years; subjects with a cessation of menses between 1 to 2 years and a follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be considered to be postmenopausal.)
    12. A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. Effective contraception is defined as a condom and at least one of the following for a female partner:
    a. Intrauterine device
    b. Occlusive cap (diaphragm or cervical/vault caps)
    c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive
    For a male subject who has had a vasectomy, use of a condom will still be required.
    13. Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after his last dose of study drug.
    14. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol.
    E.4Principal exclusion criteria
    1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator.
    2. Known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the ICF, as determined by local testing.
    3. Clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the ICF that has not been adequately treated, as determined by the Investigator.
    4. Pregnant or nursing female subjects.
    5. History of drug and/or alcohol abuse that, in the opinion of the Investigator, may prevent adherence to protocol activities.
    6. Known positive human immunodeficiency virus (HIV).
    7. Heart disease: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation. Chronic heart failure or ischemic heart disease or cardiac disease occurring as a consequence of neoplastic treatment and for which treatment medications have not added or increased in the last 3 months are not exclusionary.
    8. Known malignant tumor that may interfere with the aims of the study or a subject completing the study.
    9. Prior or planned ileal resection or bariatric surgery. Subjects who have undergone gastric surgeries that do not affect drug absorption (eg, gastric band or gastric sleeve procedures) will be allowed to participate if they are stable for at least 1 year before signing the ICF. Gastrectomy will be allowed if stable for at least 3 years before signing the ICF.
    10. Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) <50 mL/min as measured in the 3 days before signing the ICF or at Screening.
    11. Alanine transferase >5 × ULN as measured in the 3 days before signing the ICF or at Screening.
    12. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 milliseconds or other clinically relevant abnormalities as judged by the Investigator at Screening.
    13. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the CYP3A4 enzyme (Section 5.8) within 14 days before signing the ICF.
    14. Use of nonmarketed (according to region) or investigational agents, vaccines, biological products within 30 days or five half-lives before signing the ICF, whichever is longer.
    15. Use of any investigational monoclonal anti-RSV antibodies within 4 months or five half-lives of signing the ICF, whichever is longer, or use of any investigational RSV vaccines after HCT.
    16. Known hypersensitivity or allergy to EDP-938 or its excipients.
    17. History of or currently experiencing a medical condition or any other finding (including laboratory test results) that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, could prevent, limit, or confound the protocol-specified assessments, or deems the subject unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of LRTC through Day 28 defined as at least one of the following as determined by the Endpoint Adjudication Committee
    o Lower respiratory tract infection (LRTI) by RSV
    o LRTI as secondary bacterial pneumonia
    o LRTI by unusual pathogens
    o LRTC of unknown etiology
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28
    E.5.2Secondary end point(s)
    • Change in RSV RNA viral load from Baseline through Day 49 in nasopharyngeal swab samples by RT-qPCR
    • Incidence of subjects who develop respiratory failure of any cause requiring mechanical ventilation (invasive or noninvasive) or all-cause mortality through Day 49
    • Incidence of subjects with RSV RNA viral load below the lower limit of quantitation in subjects receiving EDP-938 through Day 49
    • FLU-PRO questionnaire scores through Day 49
    • Plasma PK concentrations of EDP-938 and its metabolites (EP-024636, EP-024594, and EP-024595)
    • Safety endpoints include, but are not limited to, adverse events (AEs), serious adverse events (SAEs), vital sign measurements, pulse oximetry measurements, and clinical laboratory test results (including chemistry, hematology, and urinalysis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 49
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Hong Kong
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Poland
    South Africa
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit (including Follow-up Period)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Best standard of care at investigator's discretion
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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